The following data is part of a premarket notification filed by Professional Medical Services with the FDA for Cardiac Catheterization Pack.
| Device ID | K840671 |
| 510k Number | K840671 |
| Device Name: | CARDIAC CATHETERIZATION PACK |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | PROFESSIONAL MEDICAL SERVICES 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-21 |
| Decision Date | 1984-03-12 |